The study to assess whether
voglibose could prevent
type 2 diabetes developing in high-risk Japanese subjects with
impaired glucose tolerance (IGT) were performed. This was a multicenter, randomised, double-blind, parallel group trial comparing
voglibose 0.2 mg three times a day and corresponding placebo. 1,780 eligible subjects received standard diet and
exercise therapy, and 897 were randomised to receive
voglibose and 883 placebo. The study was planned for treatment to be continued until participants developed
type 2 diabetes[primary endpoint; determined by bi-annual oral
glucose tolerance tests (OGTTs) as well as fasting
blood glucose measured every 3 months] or normalisation of the OGTT or for a minimum of 3 years, subject to the findings of an interim analysis. The interim analysis significantly favoured
voglibose and this end-of-study report involves individuals treated for an average of 48.1 weeks. Subjects treated with
voglibose had a significantly lower risk for the progression to
type 2 diabetes than placebo (50/897 vs 106/881: hazard ratio 0.595). Also, significantly more subjects in the
voglibose group achieved a normal OGTT compared with those in the placebo group (599/897 vs 454/881: hazard ratio 1.539).
Voglibose, in addition to standard care with diet and exercise, was effective in preventing the progression of IGT to
type 2 diabetes and in facilitating the normalisation of the OGTT in high-risk Japanese subjects with IGT.